Implementation and monitoring of a quality management system based on the standard UNE-EN-ISO 15189 in a urine culture unit

ObjectivesTo evaluate the implementation of a quality management system based on ISO-15189 in a urine culture unit.Design and methodsThe effectiveness of improvement actions was measured by quality indicators.ResultsThe errors in the pre-analytical phase and the rate of contaminated urine decreased significantly. The traceability, response time and external quality control were fulfilled.ConclusionsThe implementation of ISO-15189 was effective in improving the management of a urine culture unit.

► Implementation of a quality management system based on ISO 15189.
► Quality indicators to measure effectiveness of improvement actions.
► The errors in the preanalytical phase and the rate of contaminated urine decreased.
► Traceability, response time and external quality control were fulfilled.
► A continuous improvement process is necessary to maintain the achievements.